Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study

Molar Incisor Hypomineralization Clinical Trial

Official title:

Randomized Clinical Trial to Evaluate the Effectiveness of Three Remineralizing Agents on Mineral Density in Permanent Teeth and Molars With Molar Incisor Hypomineralization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362681
• Other study ID #: CF-2023-I-13
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 30, 2026

Study information

• Verified date: April 2024
• Source: Universidad Nacional Autonoma de Mexico
• Contact: Alvaro Garcia Pérez, PhD
• Phone: +525525351374
• Email: alvaro.garcia[@]unam.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico.

Description:

The study included 208 teeth with yellow-brown or creamy-white defects in children aged 6-12 years who were newly diagnosed with MIH with no substance loss or caries or prior restorative treatment. The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. The evaluations will be made based on the ICDAS criteria and the measurements which were performed using the laser fluorescence method (DIAGNOdent, KaVo, Biberach, Germany) in the follow-ups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children between 6 to 12 years
• They live in the selected study area
• Have at least one permanent incisor or molar with mild or moderate MIH (creamy white and/or yellow or brown opacities)
• That their parents authorize participation in the study through informed consent.
• No proven or suspected allergy and/or sensitivity to milk protein, as it is a component of the CPP-ACP product.

Exclusion Criteria:

• Defects in enamel development related to syndromes, dental fluorosis, amelogenesis imperfecta, dentinogenesis imperfecta.
• Presence of orthodontic appliances.
• Teeth with MIH with restorations, or severe MIH (affected enamel develops post-eruptive enamel breakdown), or carious lesions classified as score >0 according to the ICDAS.
• Children who do not show cooperation in the use of remineralizing agents.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Other:
• Fluoride
Application of remineralizing agents on teeth and molars with MIH during 24 months of follow-up.

Locations

Country	Name	City	State
Mexico	Alvaro Garcia Pérez	San Pedro Apatlaco	Morelos

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mineral Density	evaluate and compare variations in mineral density (MD) using laser induced fluorescence (LF) after applying Fluoride Varnish, Clinpro or Casein phosphopeptide amorphous calcium phosphate on teeth with Molar Incisor Hypomineralization (MIH).	24 months